This position is responsible for supporting quality and compliance in good clinical practices and oversight of SDP Oncology’s clinical trials with drug products including small molecules, peptides, and drug delivery devices. This role includes interactions with Clinical Research Organizations (CROs), local and central clinical testing laboratories, biomarker research and diagnostics laboratories, and principal investigator sites. This individual should have an interest in GCP and be highly motivated to learn.
- Execute and maintain up-to-date appropriate electronic quality management systems for deviations, investigations, CAPA, quality complaints, metrics, product review and release, record control training, and risk management as related to quality operations.
- Proficiency in the use of MasterControl and other related quality management systems.
- Support documentation of deviations, investigations, CAPAs, and audit records in a timely manner.
- Assist SDP Oncology Clinical Development, Operations, Pharmacovigilance, Data Management, and other functional areas with routine reporting of quality metrics to monitor performance and provide recommendations to senior management for continuous improvement.
- Provide quality support and contact/interface with SDP Oncology Clinical Development, Operations, Pharmacovigilance, Data Management, and partners that are based in the US, Japan, and other global locations.
- Develop and maintain meeting minutes and presentations for meetings with Quality colleagues at DSP, as required.
- Interface with Quality colleagues at DSP, as appropriate.
- Support audits of CROs, clinical investigation sites, pharmacies, clinical laboratories, and suppliers of critical services.
- Assist in the management of regulatory agency inspections both at SDP Oncology and clinical sites, laboratories, and CROs.
- Understand procedures and requirements for meeting applicable GCP, GLP, and GCLP regulations and standards.
- Write and review standards and SOPs related to Clinical Quality.
- Support a culture of quality and collaboration across the company.
- Monitor industry trends and regulatory intelligence to ensure evolution of the GCP, GLP and GCLP compliance strategy and data integrity practices.
- Establish and maintain a positive working relationship within SDP Oncology and with its external business partners as it relates to area of responsibility.
- Other duties as assigned.
- Bachelor’s degree in Biology, Chemistry, Nursing, Medical Technology, Pharmacy or a related scientific discipline is required.
- 3-4 years’ experience working in the pharmaceutical/biopharmaceutical industry with at least 1 year in a GMP, GLP or GCP-related role, or 1-4 years’ experience with advanced degree (e.g., Masters or a Pharm. D.)
- Excellent verbal and written communication skills.
- MS Office skills.
- Basic document administration skills.
- Self-motivated, able to work independently, reliable, and responsive.
- Ability to work well in both internal and external team environments, has a strong commitment to the accomplishment of tasks and adherence to procedures, and has the initiative to identify opportunities for improvements.
- Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality with attention to detail and accuracy
- Experience with electronic document management and quality systems a plus.
- Drug/device combination product experience desired.
- Experience with oncology drugs is preferred.
Job Location: Cambridge, MA
Equal Opportunity Employer
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